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Lessons learned in EU HTA Regulation’s first year

The EU Health Technology Assessment Regulation (HTAR) became operational on 12 January 2025, marking the official transition from planning to implementation for Joint Clinical Assessments (JCAs) and Joint Scientific Consultations (JSCs). The first year focused on oncology medicines and advanced therapy medicinal products (ATMPs), establishing the foundations of the new system and laying the groundwork for expansion in 2026.

The objective is to streamline and harmonise the review procedures, enabling patients to access new medications sooner. The process applies across the EU as well as to Norway, Switzerland, Ukraine and the UK. In January 2028 it will come into force for rare disease and two years later all medicinal products will follow the JCA process. This article looks at lessons learned in year one and what changes to expect in 2026. 

Key learnings from 2025

  • Scale of activity: The first year supported 10 JCAs and seven JSCs. This is relatively small given the number of oncology and advanced therapy medicinal products (ATMPs) under investigation worldwide. The number will scale significantly in 2026.
  • Process timing: The 90-day window between the release of the Population Intervention Comparator Outcomes (PICO) framework and the dossier submission is extremely tight. Advance preparation well before the formal EMA submission is recommended.
  • Evidence gaps: Initial assessments highlighted common uncertainties such as risk of bias in single-blinded trials, concerns over non-European trial locations, and inadequate handling of missing data. Patient characteristics, treatment pathways and standards of care can differ outside Europe. These variabilities can increase the uncertainty about the relevance and robustness of clinical evidence for EU decision making.
  • Institutional shift: Responsibility for HTA submissions has shifted from local country teams to global market access or health economics outcome reporting (HEOR) teams, requiring new internal playbooks for cross-functional collaboration. Among other things, playbooks should include clarification of roles and responsibilities and outline best practices and procedures. The goal is to ensure that there are agreed ways of working across the wider team.

What’s new in 2026

The 2026 Work Program anticipates a significant scale-up to approximately 50 JCAs for medicinal products. The launch of the first JCAs for high-risk medical devices will begin in June 2026. Key updates include:

  • IT infrastructure: The HTA IT Platform is now fully operational for developers to submit requests and dossiers.
  • JSC frequency: The EMA has four specific request periods for JSCs (January, April, June, and September) to provide more predictable engagement slots. The HTA Coordination Group (HTACG) anticipates eight to 12 JSCs for medicines and two to five for medical devices, reinforcing the importance of early evidence?generation planning.
  • Early expert involvement: New refinements aim to involve individual clinical experts and patients earlier in the process to improve the transparency and quality of the JCA.
  • Medical devices formally enter scope: The HTACG’s  report identifies 15 medical device categories potentially eligible for JCAs in 2026. These include implantable prosthetics, active?implantable devices, and cardiocirculatory devices. This is the first year high?risk medical devices meaningfully enter the EU?level assessment process. 

PICO data complexity

One of the more complex requirements of the JCA submissions process is the PICO framework. Health technology developers should carefully choose and appropriately define outcomes during the scoping process. This is crucial to for outcomes assessment and to expedite the submissions process. 

  • Live implementation: Since the JCA became mandatory for oncology and ATMP products, the first real-world JCAs have confirmed that PICO complexity is a practical, ongoing issue. Two of the JCA submissions entered preparation by March 2025.
  • Ongoing validation: Throughout 2025 industry bodies such as  (EFPIA) and various consulting groups have reflected on these live cases, noting that the "PICO anxiety" predicted during simulations remains a reality in the operational phase due to diverse Member State standards of care.

Current JCA pipeline

The European Commission’s  released on 20 January 2026, reflects the expanding pipeline of medicines under review. It includes 11 products: seven chemicals, two ATMPs, and two biologics.

Conclusion

The first year of the EU HTA Regulation demonstrated both its ambition and complexity. With JCAs set to expand significantly in 2026 and high?risk medical devices entering the process, sponsor success will depend on:

  • Early, proactive evidence planning
  • Stronger internal coordination across global and regional teams
  • Familiarity with the evolving JCA and JSC processes

The lessons from 2025 provide a clearer roadmap for navigating Europe’s HTA landscape. Effective collaboration and coordination between knowledgeable teams when submitting JCAs can avoid some of the missteps of the first year of the regulations. The right strategies can overcome these early challenges, leading to benefits for sponsors and, most importantly, for patients. 

Contact us to learn how 91黑料 guides sponsors through JCA requirements. 

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